Metabolic SyndromeNCT05651451
Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women
A study testing Laser acupuncture and energy-restricted diet in people with Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Thirty postmenopausal women were collected from outpatient clinic of faculty of physical therapy in Benha University to participate in this study. Their ages were ranged from 55-65 years old and their body mass index (BMI) ranged from 30 to 34.9 Kg/m2. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Laser acupuncture and energy-restricted diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Dec 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prehypertension and hypertension stage I
- overweight or obesity class I
- age 55 to 65 years
Who cannot join
- systolic blood pressure exceeding 159 mm Hg
- diastolic blood pressure exceeding 99 mm Hg,
- diabetic neuropathy disease,
- patients with mental or psychological disorders,
- skin disorders
- bleeding disorders
- musculoskeletal disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women. A Randomized Controlled Study
Thirty postmenopausal women were collected from outpatient clinic of faculty of physical therapy in Benha University to participate in this study. Their ages were ranged from 55-65 years old and their body mass index (BMI) ranged from 30 to 34.9 Kg/m2. They were divided randomly into 2 equal groups; Group A: received diet regimen, Group B: received diet regimen and treated with laser acupuncture for 30 minutes, 3 sessions per week for two months
Read the detailed description
-Group A (control group): All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.
II-Group B (study group):
All women in group (B) were received 24 activated laser acupuncture treatments. Treatments was performed 3 times per week for 8 weeks.Laser acupuncture was applied withwavelength of 810 nm, power output of 150 mW in continuous wave mode and energy density laser of 4 J/cm2 with irradiation time 3 min/point. Total duration of the training session was 30 minutes.Before starting the first treatment session, each woman was instructed briefly about the nature of the treatment to gain her confidence and cooperation. The surface of the treated skin was cleaned with alcohol wipe in order to remove any material that could absorb or disperse the radiationon the surface.The laser handheld device (laser beam spot size ≤ 36 mm2) was applied directly and perpendicularly to avoid scattering the beam, The Laser probe was applied to the surface of skin before switching on apparatus.
Laser acupuncture was applied on:
- Cv4 (Guanyuan) (3 cun inferior to the center of the umbilicus);
- Cv9 (Shuifen) (1 cun above the center of the umbilicus);
- Cv12 (Zhongwan) (4 cun above the center of the umbilicus);
- St25 (Tianshu) (2 cun lateral to the midline of the umbilicus);
- St36 (Zusanli) (one finger width lateral from the anterior crest of the tibia);
- Sp6 (Sanyinjiao) (3 cun directly above the tip of the medial malleolus);
- St40 (Fenglung) (8 cun superior to the tip of the external malleolus);
- LI4 (Hegu) (on the highest spot of the muscle when the thumb and index fingers are brought close together);
- LI11 (Quchi) (on the outside end of the crease on the elbow);
- and PC6 (Neiguan)( three finger breadths below the wrist on the inner forearm in between the two tendons.
- Conditions
- Metabolic Syndrome
- Being tested
- Laser acupuncture, energy-restricted diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureDevice
24 activated laser acupuncture treatments. Treatments was performed 3 times per week for 8 weeks.Laser acupuncture was applied withwavelength of 810 nm, power output of 150 mW in continuous wave mode and energy density laser of 4 J/cm2 with irradiation time 3 min/point
energy-restricted dietDietary supplement
All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture group | Active comparator | All women in group (B) were received 24 activated laser acupuncture treatments. Treatments was performed 3 times per week for 8 weeks.Laser acupuncture was applied withwavelength of 810 nm, power output of 150 mW in continuous wave mode and energy density laser of 4 J/cm2 with irradiation time 3 min/point. Total duration of the training session was 30 minutes.Before starting the first treatment session, each woman was instructed briefly about the nature of the treatment to gain her confidence and cooperation. The surface of the treated skin was cleaned with alcohol wipe in order to remove any material that could absorb or disperse the radiationon the surface.The laser handheld device (laser beam spot size ≤ 36 mm2) was applied directly and perpendicularly to avoid scattering the beam, The Laser probe was applied to the surface of skin before switching on apparatus. Receives: Device: Laser acupuncture; Dietary Supplement: energy-restricted diet |
| Diet regimen group | Active comparator | All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E Receives: Dietary Supplement: energy-restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile TG
Triglycerides in mmol/L will be measured
Measured: 8 weeks after treatment
Lipid profile HDL
High density lipoprotein in mmol/L will be measured
Measured: 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start22 Dec 2022
- Primary completion18 Jul 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed M Maged, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651451
- Sponsor's protocol ID
- 67
- Status last verified
- May 2024
- First submitted
- 6 Dec 2022
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture on Metabolic Syndrome in Obese Postmenopausal Women. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05651451
- Acronym / sponsor ID
- 67
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirty postmenopausal women were collected from outpatient clinic of faculty of physical therapy in Benha University to participate in this study. Their ages were ranged from 55-65 years old and their body mass index (BMI) ranged from 30 to 34.9 Kg/m2. They were divided randomly into 2 equal groups; Group A: received diet regimen, Group B: received diet regimen and treated with laser acupuncture for 30 minutes, 3 sessions per week for two months
Detailed description
-Group A (control group): All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.
II-Group B (study group):
All women in group (B) were received 24 activated laser acupuncture treatments. Treatments was performed 3 times per week for 8 weeks.Laser acupuncture was applied withwavelength of 810 nm, power output of 150 mW in continuous wave mode and energy density laser of 4 J/cm2 with irradiation time 3 min/point. Total duration of the training session was 30 minutes.Before starting the first treatment session, each woman was instructed briefly about the nature of the treatment to gain her confidence and cooperation. The surface of the treated skin was cleaned with alcohol wipe in order to remove any material that could absorb or disperse the radiationon the surface.The laser handheld device (laser beam spot size ≤ 36 mm2) was applied directly and perpendicularly to avoid scattering the beam, The Laser probe was applied to the surface of skin before switching on apparatus.
Laser acupuncture was applied on:
- Cv4 (Guanyuan) (3 cun inferior to the center of the umbilicus);
- Cv9 (Shuifen) (1 cun above the center of the umbilicus);
- Cv12 (Zhongwan) (4 cun above the center of the umbilicus);
- St25 (Tianshu) (2 cun lateral to the midline of the umbilicus);
- St36 (Zusanli) (one finger width lateral from the anterior crest of the tibia);
- Sp6 (Sanyinjiao) (3 cun directly above the tip of the medial malleolus);
- St40 (Fenglung) (8 cun superior to the tip of the external malleolus);
- LI4 (Hegu) (on the highest spot of the muscle when the thumb and index fingers are brought close together);
- LI11 (Quchi) (on the outside end of the crease on the elbow);
- and PC6 (Neiguan)( three finger breadths below the wrist on the inner forearm in between the two tendons.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture group | Active comparator | Device: Laser acupuncture, Dietary Supplement: energy-restricted dietAll women in group (B) were received 24 activated laser acupuncture treatments. Treatments was performed 3 times per week for 8 weeks.Laser acupuncture was applied withwavelength of 810 nm, power output of 150 mW in continuous wave mode and energy density laser of 4 J/cm2 with irradiation time 3 min/point. Total duration of the training session was 30 minutes.Before starting the first treatment session, each woman was instructed briefly about the nature of the treatment to gain her confidence and cooperation. The surface of the treated skin was cleaned with alcohol wipe in order to remove any material that could absorb or disperse the radiationon the surface.The laser handheld device (laser beam spot size ≤ 36 mm2) was applied directly and perpendicularly to avoid scattering the beam, The Laser probe was applied to the surface of skin before switching on apparatus. |
| Diet regimen group | Active comparator | Dietary Supplement: energy-restricted dietAll post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prehypertension and hypertension stage I
- overweight or obesity class I
- age 55 to 65 years
Key exclusion criteria (7 listed)
- systolic blood pressure exceeding 159 mm Hg
- diastolic blood pressure exceeding 99 mm Hg,
- diabetic neuropathy disease,
- patients with mental or psychological disorders,
- skin disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser acupuncture24 activated laser acupuncture treatments. Treatments was performed 3 times per week for 8 weeks.Laser acupuncture was applied withwavelength of 810 nm, power output of 150 mW in continuous wave mode and energy density laser of 4 J/cm2 with irradiation time 3 min/point | Device | Laser acupuncture group |
| energy-restricted dietAll post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E | Dietary supplement | Diet regimen group, Laser acupuncture group |
Primary outcome
Lipid profile TG
Time frame: 8 weeks after treatment
Triglycerides in mmol/L will be measured
Lipid profile HDL
Time frame: 8 weeks after treatment
High density lipoprotein in mmol/L will be measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Maged principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture and energy-restricted diet in people with Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile TG (time frame: 8 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.